Study of ART6043 in Advanced/Metastatic Solid Tumors

This study is looking at a new oral medicine called ART6043, by itself or with another oral medicine called olaparib, for people with advanced or metastatic (spread) solid tumors. Researchers want to see how safe ART6043 is, how your body handles it, and if it helps shrink tumors. Some parts of the study will focus on people whose cancers have specific genetic changes, like in the BRCA gene, or are HER2-negative. You might be able to join if you are 18 or older and have stopped previous cancer treatments for a certain time. The study will measure how many people have side effects and how long people live without their cancer getting worse. This study plans to enroll 181 participants, but its current status is unclear.

Study design: This is an interventional study, meaning participants will receive specific treatments. It involves two parts: a dose-finding phase and a phase to further confirm safety and initial effectiveness.
What's involved: You will receive ART6043 and/or olaparib orally. You may continue treatment as long as your doctor believes it is helping, or until side effects become too much, or your cancer progresses.
Compensation: Not stated in the trial record.
Follow-up: For some participants, progression-free survival will be measured until disease progression, which could be up to 3.7 years.

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Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

Recruiting

PHASE1Ages 18+InterventionalTreatment

Artios Pharma Ltd

~181 participants

Updated 2026-05-01 on ClinicalTrials.gov

What's tested:ART6043Olaparib

At a glance

Recruiting sites

5 of 12 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Part A: Number of participants with Dose Limiting Toxicities (DLTs)

Measured over From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)

+1 more outcome measured

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Where it's being run

12 sites across 11 states

Texas2

Michigan1

New York1

Oklahoma1

Pennsylvania1

Tennessee1

Andalusia1

Castille and León1

Who to contact

Artios Pharma

[email protected]

+44 (0)1223 867 900

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients who have discontinued all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Endocrine and hormonal therapies for the treatment of cancer must have been discontinued (unless for the treatment of Prostate Cancer) at least 7 days before receiving study medication. Palliative radiotherapy must have completed prior to start of study treatment.

Resolution of all toxicities of prior therapy or surgical procedures.

Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.

Have adequate organ function.

Patients of childbearing potential and patients with partners of childbearing potential are required to use highly effective contraception.

Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.

Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes based on available, pre-existing testing.

Patients for whom a PARPi is an appropriate treatment option. Patients may have received prior treatment with a PARPi.

Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.

Documentation of a deleterious or suspected deleterious gBRCA mutation.

Previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting unless medically contraindicated.

Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.

Patients must have received no or ≤1 month of prior treatment with a PARPi.

Exclusion

Patients who are pregnant.

Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

Have ongoing interstitial lung disease or pneumonitis.

Have any major gastrointestinal issues that could impact absorption of ART6043 or olaparib.

Patients with brain metastases (patients with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression).

Have received a live vaccine within 30 days before the first dose of study treatment.

Recent major surgery within 4 weeks prior to entry into the study.

Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.

Have a history of allergy or hypersensitivity to study drug components.

First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.

Inflammatory breast cancer.

What this trial measures

Part A: Number of participants with Dose Limiting Toxicities (DLTs)From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Part B2: Progression free survival (PFS)Until disease progression (Upto 3.7 years).
PFS is defined as the time from randomization until objective disease progression as defined by Response evaluation criteria in solid tumors (RECIST) v1.1 or death by any cause in the absence of progression, regardless of whether the patient withdraws from study medication or receives another anti-cancer therapy prior to progression.

Trialytics